PRODUCTNAME NOBIVAC RABIES 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Rabies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active components: Rabies strain Pasteur RIV; at least 2 I.U. per dose Preservative: Thiomersal 0.01% 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 Target species Dogs, cats, cattle, sheep, goats, foxes, ferrets and horses. 4.2 Indications for use specifying the target species (if appropriate) For the active immunisation of healthy dogs, cats, cattle, sheep, goats, ferrets, foxes and horses, and in principle all healthy mammals against rabies. 4.3 Contraindications None 4.4 Special warnings None 4.5 Special precautions for use Allow the vaccine to reach ambient temperature (15-25 C) before use. Use sterile injection equipment. Shake before and during use. Special precautions for use in animals Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals None 4.6 Adverse reactions (frequency and seriousness) After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection. Generalised hypersensitivity reactions following administration may occasionally occur. 4.7 Use during pregnancy and lactation Can be used during pregnancy in dogs.
PRODUCTNAME NOBIVAC RABIES 4.8 Interaction with other medicinal products and other forms of interaction Nobivac Rabies can be used to reconstitute the freeze-dried canine vaccines of the Nobivac series. Nobivac Rabies can be administered with the Nobivac leptospirosis vaccines at the same time but at a different administration site. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 4.9 Amounts to be administered and administration route 1 ml by subcutaneous or intramuscular injection. 4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary) After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection. 4.11 Withdrawal period(s) Not applicable. 5. IMMUNOLOGICAL PROPERTIES Inactivated viral vaccine ATC vet code for dogs: QI07AA02 Induction of active immunity against rabies. 6. PHARMACEUTICAL PARTICULARS 6.1 Incompatibilities Do not mix with any other veterinary medicinal product except the vaccines of the Nobivac series mentioned in section 4.8. 6.2 Shelf life At least 4 years at 2-8 C. Broached vials of the 10-dose presentation should be used within one working day. 6.3 Special precautions for storage Store at 2-8 C. Protect from light. 6.4 Nature and composition of immediate packaging Glass vials closed with a rubber stopper, and sealed with an aluminium cap. 6.5 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities. 7. MARKETING AUTHORISATION HOLDER Intervet International B.V. Wim de Körverstraat 35 Boxmeer The Netherlands
Annex A. Labelling ANNEX A. LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Rabies 2. PACKAGE SIZE 10x1 dose 50x1 dose 10x10 doses 3. INDICATION(S) Inactivated vaccine containing 2 I.U. rabies virus strain Pasteur RIV per dose. Preservative: Thiomersal 0.01%. 4. EXPIRY DATE Expiry {month/year} Mfg.date {month/year} 5. SPECIAL STORAGE CONDITIONS Store at 2-8 C. Protect from light. 6. THE WORDS FOR ANIMAL TREATMENT ONLY AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. 7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. Boxmeer The Netherlands 8. MARKETING AUTHORISATION NUMBER(S) 9. MANUFACTURER S BATCH NUMBER Batch {number}
Annex A. Labelling MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Rabies 2. INDICATION(S) Inactivated rabies vaccine 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose 10 doses 4. SPECIAL STORAGE CONDITIONS Store between 2-8 C. Protect from light. 5. BATCH NUMBER Batch {number} 6. EXPIRY DATE Expiry {month/year} Mfg.date {month/year} 7. THE WORDS FOR ANIMAL TREATMENT ONLY For animal treatment only.
Annex B. Package leaflet ANNEX B. PACKAGE LEAFLET Nobivac Rabies FOR ANIMAL TREATMENT ONLY DESCRIPTION This vaccine contains an inactivated culture of rabies virus, cloned out of strain Pasteur RIV with a potency of 2 I.U. The virus is grown on the BHK-21 clone CT cell line and inactivated with beta-propiolactone. It is presented as an aluminium phosphate adsorbed vaccine. COMPOSITION Active components: Rabies strain Pasteur RIV: at least 2 I.U. per dose. Preservative: Thiomersal 0.01% INDICATION For the active immunisation of healthy dogs, cats, cattle, sheep, goats, ferrets, foxes and horses, and in principle all healthy mammals against rabies. DOSAGE AND ADMINISTRATION 1 ml by subcutaneous or intramuscular injection. RECOMMENDED VACCINATION PROGRAMME Primary vaccination at an age of more than Dogs/Cats Cattle/Horses Ferrets 3 months* 6 months* 3 months* Revaccination every 3 years** 2 years** 1 year** Route of administration i.m. or s.c. i.m. s.c. * Primary vaccination can be administered at an earlier age, but then a repeat vaccination must be given at the age of 3 or 6 months depending on the species. ** Recommended revaccination interval is based upon results from challenge experiments. Local regulations in force may require earlier revaccination. Results from serological investigations indicate that vaccination of sheep, goats, and foxes provides protection for at least one year. VACCINATION REACTIONS After subcutaneous administration occasionally a transient palpable nodule may occur at the site of injection.
Annex B. Package leaflet NOTE - Vaccinate healthy animals only. - Generalised hypersensitivity reactions following administration may occasionally occur. - Allow the vaccine to reach ambient temperature (15-25 C) before use. - Use sterile injection equipment. - Shake before and during use. - Nobivac Rabies can be used to reconstitute the freeze-dried canine vaccines of the Nobivac series. - Nobivac Rabies can be administered with the Nobivac leptospirosis vaccines at the same time but at a different administration site. - Keep out of the reach and sight of children. IMMUNITY In dogs, peak antibody titres have been demonstrated to occur by 3 weeks after vaccination. STORAGE Store at 2-8 C. For the 10 dose presentation, broached vials should be used within one working day. PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL No special precautions are required. Dispose by the appropriate channels. PACKING Vials containing 1 or 10 doses. Product of: INTERVET INTERNATIONAL B.V. BOXMEER THE NETHERLANDS